3-D printing in spine: Insights from Mighty Oak Medical

Surface Technology

3-D printed surgical guides may offer an alternative to intraoperative imaging as a simple, convenient and low-cost way to improve pedicle screw placement accuracy.

Denver-based Mighty Oak Medical offers 3-D printed FIREFLY patient-specific pedicle screw navigation guides. In a recent interview with Becker's Spine Review, Mighty Oak Medical President Heidi Frey, COO Brent Ness and Chief Technology Officer Brad Clayton shared insights on 3-D printing in spine. 

Question: How can 3-D printing optimize spine surgery? 

Brad Clayton: The operating room is an environment where accuracy is essential to ensuring optimal patient outcomes. Some surgeons are bringing complicated and expensive capital equipment into the OR to achieve greater accuracy, but this equipment is not universally available and can create its own set of problems.

FIREFLY Technology is an alternative that uses 3-D printing to create guides for each vertebral level and a biocompatible bone model that is an exact replica of the patient's spine. Screw trajectories determined by the concierge presurgical planning process are incorporated into the model for real-time surgeon reference intraoperatively.

Knowing the screw size can help the surgical team deliver the appropriate screw loaded onto the driver prior to the surgeon probing, calculating size and requesting the implant.  Confirming the 3-D printed guide's fit on the autoclavable bone model prior to placement on the patient's anatomy helps the surgeon gain haptic feedback on how the guide should feel when placed appropriately. 

Q: What is the benefit of 3-D printed patient-specific guides for spine surgeons and patients? 

Heidi Frey: The benefits include screw placement accuracy, improved OR efficiency and reduced intraoperative radiation. For hospitals and surgery centers, there is no risk of equipment obsolescence and no upfront capital expenditure. For patients, the increased screw placement accuracy should result in less need for revision surgery. Mighty Oak Medical believes that there is no one-size-fits-all navigation solution, and that navigation should be a menu of options.

Q: How can FIREFLY technology expand and improve access to care?

Brent Ness: FIREFLY patient-specific technology essentially converts spinal navigation for open surgeries from a complex and high investment technology to a high-tech disposable that is intuitive and affordable. Many surgeons around the world do not have access to million dollar optical navigation and robotic systems, but they do have access to a CT scanner.

With the data from one preoperative CT, we can create a virtual spine in 3-D, help the surgeon select the optimal screw trajectories and predetermine the screw sizes.

After the surgeon approves the plan, we design guides to constrain the drill and tap to follow those trajectories. All of this planning occurs before the surgery, so that the surgeon can concentrate on the patient and perform the surgery with the assistance of a simple patient-specific guide. Our motto is "Navigate. Don't complicate." Surgeons have enough on their plate during a complex spine surgery without the navigation system slowing down the case or complicating it. 

Q: How can FIREFLY serve as an alternative to standard intraoperative medical imaging?

HF: FIREFLY does not require any fluoroscopy to place pedicle screws.  The newest generation of CT scanners can produce images with all the data we need to create patient-specific guides and exact bone model replicas of the patient's spine, with an ever-decreasing radiation dose to the patient and none to the OR staff and surgeon. This controlled use of preoperative CT imaging, as opposed to using intraoperative fluoro or CT that may require multiple images or spins in a longer construct case, can be a very compelling choice for clinicians and hospitals.   

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